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Clinical Study to Assess Safety and Effectiveness of the Zenith® Dissection Endovascular System in Patients With Aortic Dissection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00526487
Recruitment Status : Completed
First Posted : September 10, 2007
Last Update Posted : March 1, 2017
Sponsor:
Collaborators:
Cook Group Incorporated
MED Institute, Incorporated
William Cook Australia
Information provided by (Responsible Party):
Cook Group Incorporated ( William Cook Europe )

Tracking Information
First Submitted Date  ICMJE September 5, 2007
First Posted Date  ICMJE September 10, 2007
Last Update Posted Date March 1, 2017
Study Start Date  ICMJE December 2007
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2007)
The primary endpoint is survival at 30 days [ Time Frame: 30 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 6, 2007)
The primary endpoint is survival at 30 days
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2007)
Measure: Clinical utility, incidence and rate of adverse events, mortality, factors related to morbidity [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study to Assess Safety and Effectiveness of the Zenith® Dissection Endovascular System in Patients With Aortic Dissection
Official Title  ICMJE Evaluation of the Safety and Effectiveness Performance of the Zenith® Dissection Endovascular System in the Treatment of Patients With Aortic Dissection Involving the Descending Thoracic Aorta
Brief Summary The purpose of this study is to evaluate the safety and effectiveness performance of the Zenith® Dissection Endovascular System in the treatment of aortic dissections involving the descending thoracic aorta.
Detailed Description The Zenith® Thoracic Dissection Study is a clinical trial to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of dissections (length-wise tear) of the descending thoracic aorta. The Zenith® Dissection Endovascular System is comprised of the Zenith TX2® TAA Endovascular Graft and the Zenith® Dissection Endovascular Stent. Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the graft and the dissection stent into place in the aorta.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Aortic Dissection Involving the Descending Thoracic Aorta
Intervention  ICMJE
  • Device: Zenith® Dissection Endovascular System
    The Zenith® Thoracic Dissection Study is a clinical trial to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of dissections (length-wise tear) of the descending thoracic aorta. The Zenith® Dissection Endovascular System is comprised of the Zenith TX2® TAA Endovascular Graft and the Zenith® Dissection Endovascular Stent. Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the graft and the dissection stent into place in the aorta.
  • Device: Endovascular Repair
    Endovascular Repair
Study Arms  ICMJE 1
Endovascular Repair
Interventions:
  • Device: Zenith® Dissection Endovascular System
  • Device: Endovascular Repair
Publications * Lombardi JV, Cambria RP, Nienaber CA, Chiesa R, Mossop P, Haulon S, Zhou Q; STABLE I Investigators. Five-year results from the Study of Thoracic Aortic Type B Dissection Using Endoluminal Repair (STABLE I) study of endovascular treatment of complicated type B aortic dissection using a composite device design. J Vasc Surg. 2019 Oct;70(4):1072-1081.e2. doi: 10.1016/j.jvs.2019.01.089. Epub 2019 May 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 12, 2010)
60
Original Estimated Enrollment  ICMJE
 (submitted: September 6, 2007)
40
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Branch vessel obstruction/compromise
  • Peri-aortic effusion/hematoma
  • Resistant hypertension
  • Persistent pain/symptoms
  • Transaortic growth greater than or equal to 5 mm within 3 months (or transaortic diameter greater than or equal to 40 mm)

Exclusion Criteria:

  • Age less than 18 years
  • Frank rupture
  • Diagnosed or suspected congenital degenerative connective tissue disease
  • Systemic infection
  • Untreatable reaction to contrast
  • Surgical/endovascular AAA repair within 30 days
  • Previous placement of thoracic endovascular graft
  • Prior repair of descending thoracic aorta
  • Interventional/open procedures within 30 days
  • Onset of symptoms > 3 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Czech Republic,   France,   Germany,   Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00526487
Other Study ID Numbers  ICMJE 07-004
370010, TXD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cook Group Incorporated ( William Cook Europe )
Study Sponsor  ICMJE William Cook Europe
Collaborators  ICMJE
  • Cook Group Incorporated
  • MED Institute, Incorporated
  • William Cook Australia
Investigators  ICMJE
Principal Investigator: Joseph Lombardi, MD Thomas Jefferson University
PRS Account Cook Group Incorporated
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP